Trial reportBMC endocrine disorders2025
Effect of empagliflozin on liver fibrosis and steatosis in patients with type 2 diabetes and non-alcoholic fatty liver disease: a randomized clinical trial.
Trial report in BMC endocrine disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- SGLT2 inhibitors and incretin-based therapies for metabolic dysfunction-associated steatohepatitis: a systematic review.European journal of clinical pharmacology · 2026Pooled it
- Hepatoprotective effects of empagliflozin in metabolic dysfunction-associated steatotic liver disease: a systematic review and meta-analysis of preclinical studies.Frontiers in pharmacology · 2026Pooled it
- Selective SGLT2 inhibitors in MASLD/MASH: an outcome-specific systematic review and meta-analysis of hepatic and cardiometabolic outcomes.Acta diabetologica · 2026Review
- Empagliflozin attenuates dexamethasone-induced non-alcoholic steatohepatitis by regulation of ferroptosis, inflammation and autophagy.Frontiers in pharmacology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimMetabolic dysfunction-associated steatotic (MASLD) is a common complication in diabetic patients that can lead to fibrosis and severe liver complications. This study aimed to investigate the effect of empagliflozin on liver markers and fibrosis in diabetic patients with NAFLD.
methodsThis was a single-center, randomized, controlled, phase II clinical trial including 119 patients with type 2 diabetes and MASLD. Patients were randomized to receive either empagliflozin (10 mg or 25 mg daily) or standard care for 6 months. Liver enzymes, imaging scores (MRI and ultrasound), and fibrosis indices (FIB-4 and NFS) were assessed at baseline and at study completion. Statistical analyses included between- and within-group comparisons, adjusted models for baseline imbalances and age.
resultsEmpagliflozin significantly reduced liver enzymes compared with controls (ALT − 41.2 vs. −4.6 IU/L; AST − 18.4 vs. −3.3 IU/L; GGT − 25.5 vs. −2.2 IU/L; all p < 0.001). The FIB-4 index decreased in the intervention group (1.20→1.06, p < 0.001) but not in controls (1.42→1.42, p = 0.233). The NAFLD fibrosis score showed no significant change. Imaging confirmed greater improvement in the empagliflozin group, with 94% showing grade 1 or lower steatosis on ultrasound and 100% achieving grade 0 on MRI (p < 0.001 for both). Importantly, complementary analyses (ANCOVA and mixed models) demonstrated that these improvements remained significant after adjustment for age and baseline values.
conclusionEmpagliflozin significantly improved liver enzymes, imaging scores, and FIB-4 in patients with T2DM and MASLD. These findings support its potential as a therapeutic option in metabolic liver disease and highlight the need for longer, multicenter trials to confirm sustained benefits and to explore combination strategies with other agents. CLINICAL
trial registrationThis study is related to a previously registered clinical trial conducted at Loqman-e-Hakim Hospital. The clinical trial was registered with the Iranian Registry of Clinical Trials under the number IRCT20210811052150N1.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.